Tampa, Fla.-based Keystone Heart developed and produces TriGuard embolic protection devices, which are designed to protect the brain from emboli during transcatheter aortic valve replacement and other heart procedures to reduce stroke risk and brain damage.
“We are excited to be joining a truly entrepreneurial company like Venus. Providing brain protection for every TAVR patient will differentiate Venus Medtech and position them as a leader in structural heart therapies – underscoring its dedication to excellence, determination to provide a total solution for patients undergoing TAVR procedures and focus on patient safety. This partnership provides us the unique opportunity to improve the lives of patients undergoing structural heart procedures with cerebral embolic protection and the ability of bringing new cutting-edge therapies into the US & EMEA,” Keystone Heart prez & CEO Chris Richardson said in a press release
Venus Medtech said that Keystone is currently enrolling people in a trial looking to evaluate the TriGuard 3, and that it is hopeful it will complete enrollment in the first quarter of 2019 with a hoped for FDA review during the first half of next year. Keystone Heart is hopeful for CE Mark approval in the European Union by the end of this year.
“It is of utmost importance to us that our devices improve the quality life of the patients whom receive them. Our transcatheter heart valve systems offer patients life-saving support – acquiring Keystone Heart allows us the opportunity not only to reduce the risk of brain injury during cardiac procedures but establishes our presence in the US and EMEA through which we can introduce our entire portfolio of products,” Venus Medtech CEO Eric Zi said in a prepared statement.
Venus Medtech said that it expects the merger will close during the fourth quarter of this year, but is subject to customary closing conditions.
In June, Venus Medtech said that it launched its Venus P-Valve self-expanding pulmonary valve implant in Canada, touting that the first procedures with the valve have been performed in the region.